Archive for the ‘Suboxone film’ Category

This week, officials of Reckitt-Benckiser, the pharmaceutical company that manufactures Suboxone and Subutex, announced its plan to stop manufacturing Suboxone tablets. The drug company says the tablets will be phased out over the next six months. According to their press releases, the company decided to discontinue manufacture of Suboxone tablets, “Because of strong evidence that the tablet form of Suboxone is linked to significantly higher rates of pediatric exposure as compared with…the film.”

Reckitt Benckiser says they are basing their action on data from the Poison Control center from September that showed there were around 8 times as many accidental Suboxone exposures in children with tablets versus films. They say they are taking action in the interest of public health.

The drug company says that since the films and tablets are clinically interchangeable, patients presently taking tablets won’t be adversely affected.

In the most recent issue of Alcohol and Drug Abuse Weekly, a spokesman for the company said per 10,000 Suboxone patients, there were .71 pediatric exposures to the film and 6.25 pediatric exposures to the tablets. These numbers were statistically significant. (1)

I believe their data. It makes sense that children would have a harder time opening one of those foil packets of Suboxone film than opening a prescription bottle of tablets. Plus, with a bottle there’s more than one dose available for ingestion, while one packet yields only one potential dose. The tablets also have an orange-y smell and taste, and may be more appealing to young children than other types of pills.

I also think Reckitt Benckiser’s film is a better product than their tablet. Most of my patients do prefer the film, saying it dissolves faster and tastes better.

However…maybe I’m too cynical when it comes to drug companies, but I don’t believe pediatric exposure is the only reason the drug company is ceasing manufacture of the tablets. I think it’s also a financial decision. The film’s patent doesn’t expire for more than ten more years, while the tablet’s patent has already expired. The Reckitt Benckiser rep for my area told me months ago that the company was considering taking the tablets off the market.

I think the recent data about pediatric overdose with tablets gave RB a great excuse to pull their tablets off the market, “For the kids…” The drug company would be open to criticism if they pulled the tablets for a purely financial motive, but who could criticize a drug company for trying to prevent the death of children? I do wonder how pediatric overdose rates of Suboxone tablets compares with other prescription opioids, but after scouring the internet can’t find that information.

I wondered how RB’s decision will affect my patients. I’m worried about a small number of my patients who, for whatever reason, didn’t like the films. These patients are all doing great in their recovery, and show no sign of medication diversion. They aren’t “bad” patients trying to scheme a way to misuse medications. Many of them have been in stable recovery, assisted by Suboxone tablets, for more than three years. All tried the film when it was released, and found it lacking. Some patients didn’t like how the films were crumbling, a problem that seems to have resolved over the last six months. I have about twenty-five people in my practice who prefer Suboxone tablets to films.

Today in my office practice I saw three patients of these patients. All of them, by the way, keep their medication locked up and safely away from children. I explained the situation to them, and told them I would like to switch them to the film, because the tablets were going to be phased out over the next six months. Two grudgingly said they would switch but wanted to wait until it was absolutely necessary. The third said he’s prefer to switch to the generic buprenorphine tablets, because he hated the film and didn’t feel like it worked nearly as well.

Overall I don’t like to prescribe generic buprenorphine in the office, because it has higher street value and is easier to misuse. Since the generic buprenorphine has no naloxone in it, it can be injected. I don’t usually prescribe it unless the patient has no insurance, is stable in their recovery with no recent IV drug use, and can’t afford name brand Suboxone. In my area, the generic buprenorphine tablets are less than half the cost of either Suboxone film or tablet. For some patients, being able to buy the cheaper generic has made it possible for them to afford to remain in treatment. Their other option would be to go to the methadone clinic, and many patients prefer treatment in an office setting, obviously.

My patient today has been in recovery for three years. He has a sponsor, goes to 12-step meetings several times per week, has never had a positive drug screen the whole three years, has a stable home, wife, kids, and also finds time to help his aging parents. I’m going to prescribe generic buprenorphine tablets for him.

This won’t be the right answer for all my patients. Some will have to try the Suboxone films again, and I hope that will work for them.

Because of this pediatric overdose information I’m going to ask every patient – on films or tablets – how they store their medication, to make sure it’s safe.

When my Suboxone patients are ready to taper off the medication, I prefer to use the film. Since the film is no longer crumbling, patients can take sharp scissors or a knife and cut the films into smaller pieces roughly equal in size, ideal for a taper. Yes, I know the manufacturer says we shouldn’t cut the film or the tabs, because they have not done studies to see if the medication is equally distributed throughout the entire film or tablet. But cutting is a great way to taper, it seems to work, and everybody’s been doing it since Suboxone came out in 2003.

Most of my patients who successfully tapered off were on Suboxone at least two years, and did the work of counseling before attempting a taper. Most recent studies show high relapse rates if tapered too soon, probably because it takes time to get the essential counseling and make life changes that support a new life without drugs.

How long should the ideal taper take? It depends on the patient’s tolerance of opioid withdrawal symptoms. I’ve been telling patients four to six months is an average taper. I’ve been decreasing the dose by 2 mg every 2 weeks, until the patient is at 8mg or less. Most patients tolerate that fairly well, though patients differ markedly in their tolerance of withdrawal. At any time in the taper, if the patient starts feeling more withdrawal than they can tolerate, we can go back up a little, or plateau at a dose for a month or so.

Below 8mg, I reduce the dose more slowly, since each milligram is a bigger percent of the whole dose. I’ve been trying to decrease patients by 2mg every 4 weeks. This way when I see them every month, we talk about how they’re feeling, and if they’ve had a relapse (With any relapse to opioids, we go back up on the dose and work more on relapse prevention). For an 8mg film, this can be accomplished easily, by cutting the film into fourths. That’s a 25% drop in a month, or around 6.25% drop per week, at least at first. It’s common to have to stay on 4 or 2 mg for longer than a month.

Once the patient is down to 2mg, I switch to the 2mg film, and again have the patient divide it into fourths. I still try to drop by one-quarter of the film per month, meaning a half of a milligram decrease each month.

Sometimes we seem to get stuck at a dose. For example, I have a patient on a 2mg tab, which can be cut in half but is too small to reliably cut into fourths. He’s been trying to drop to 1mg but can’t tolerate staying at that dose for more than a day or two. So at his last visit, we decided he would alternate 1mg per day with 2mg per day. He did better with that, and now we are trying two days of 1mg and one day of 2mg, in a cycle every three days.

Then today, in my latest issue of American Journal on Addictions, there’s an article that throws a monkey wrench into my ideas around tapering.

This article has case reports of four patients who stopped Suboxone suddenly, unplanned. They were on doses ranging from 12mg per day to 30mg per day, and all four had only one or two days of mild opioid withdrawal, then felt fine. The author concluded that these patients, “Showed no objective signs of opiate withdrawal following abrupt discontinuation of chronic buprenorphine/naloxone treatment…” The authors postulated that a prolonged taper might actually be harder on patients than stopping suddenly at a higher dose, based on these four case studies and other doctors’ impressions. Three of the four patients returned to buprenorphine/naloxone treatment when they had the opportunity, for fears of relapse, and the fourth was felt not to be appropriate for continued treatment with buprenorphine.

Could this be true? Might it be easier for patients to stop at a higher dose, rather than taper to a lower dose? Intuitively, a taper seems to be the best way to avoid withdrawal symptoms, but what if buprenorphine is different? It is an unusual drug. It’s a partial opioid agonist at the mu receptors, but it also has action on other opioid receptors. Might the action at other types of receptors be responsible for what was seen in those case studies? What about the monoproduct, Subutex?

I’m so intrigued by these case reports that I’d love to see a large randomized trial to answer these questions. I have seen a few patients stop taking medication suddenly at higher doses and they said they didn’t have bad withdrawals…but then I have had many others who stopped suddenly and had terrible withdrawals.

In the past, I’ve blogged about how some of my patients were having problems with their Suboxone films. When they opened the foil packets, the films were broken into pieces or so fragile they broke when handled. But now over the last two or three months, my patients tell me the films are no longer breaking or fragile, making them easier to use.

I’m glad. The Reckitt Benckiser drug company, manufacturer of Suboxone, wants doctors to switch patients to film because it dissolves faster, is easier to use, is less dangerous to children because the package is so hard to open, and it’s less likely to be snorted. They also say it’s harder to divert and has less value on the black market. And they say tablets are more likely to trigger patients who were addicted to tablets.

There’s validity to much of that, but I believe the biggest reason they want patients to switch is because their patent on the film runs for at least seven more years. Call me cynical.

About half of my patients who tried the film didn’t like it. Nearly all were patients in good recovery, stable for months to years, and if they wanted to tablets rather than the film, I was OK with that. When the film became crumbly, a few more patients wanted to switch back to the tablets.

Now, I’m more enthusiastic about the films. I can prescribe the film with more confidence since they no longer crumble. I prefer to use the films for patients tapering off Suboxone. I know the drug company says the films (and tablets) shouldn’t be cut, but of course everyone has been cutting both. With sharp scissors, the films can be cut into equal and small portions, ideal for a gradual taper of the dose.

I have more success with tapers in patients taking the film. In my next blog, I’ll talk about some of the “recipes” for taper my patients and I have used.

Last week, one of my office-based buprenorphine patients asked me how I thought the new healthcare laws would affect my business. I’ve considered this question with a mix of anxiety and hope. Until we have more details, I’m not certain I’ll like the new changes. And of course since I’m a healthcare provider, I’ll look at changes differently than if I were an insurance executive.

I told my patient that it will be excellent for my patients in buprenorphine (Suboxone, Subutex) treatment who don’t have insurance now, and are paying out of pocket. My patient then remarked that I’ll be much busier, because more pain pill addicts will be able to afford treatment.

“No,” I said, “I can still only have one hundred Suboxone patients at any one time, so I can’t add any new patients.”

My patient was quiet for a moment and said, “So if an addict calls you because he just got insurance to pay for his treatment, you couldn’t see him anyway?”

“That’s right, unless I lost a patient for some reason, and had an open spot for him.”

“So even if addicts get insurance, they can’t use it? That’s crazy. Why does the government have that law?”

I explained to him about the newness of the DATA 2000 Act, and that some lawmakers were skittish about this program from the beginning. They were worried Suboxone “mills” would open, where hundreds of addicts were treated with little physician oversight or precautions.

Lifting that limit would be the easiest way to get more opioid addicts into treatment.

My private practice, where I treat opioid addicts with buprenorphine (Suboxone, Subutex), is a bare bones operation. Because of the one hundred patient limit, I have enough patients to keep me busy for one day per week. On the other days, I work at opioid treatment programs. I enjoy my own office practice because of the autonomy, and because I have some great patients that I’ve known for years. But at my own office, I make far less than half what I make at the opioid treatment programs.

I have the usual fixed overhead of rent, utilities, answering service, internet, etc., and most of the money I take in goes towards that. I have a part-time health care coordinator, who makes appointments for patients, calls them to remind them of appointments, does most of my office drug screens, screens my after-hours calls, handles the filing, copying and other record-keeping tasks, and deals with those pesky pre-authorization requests that insurance companies make. (She and the counselor have decided I ought not to be allowed to talk with the insurance companies, since I often erupt into profanity).Then I have the best LCAS (Licensed Clinical Addiction Specialist) counselor in the world who works with me on Fridays, doing individual counseling (he’s my fiancé). Since I don’t file insurance, but rather give the patient a receipt so they can file it themselves, I avoid that personnel expense.

And I don’t accept Medicaid or Medicare as payment for treatment. I feel guilty for admitting that, but I don’t think I could stay in practice if I accepted what these government programs pay for treatment. When I first opened my own office in 2010, I saw a handful of these patients for free, since trying to file and going through the necessary red tape isn’t worth the pittance these programs pay for an office visit.

So if my uninsured patients get Medicaid, I’ll have to decide how to deal with that problem.

It’s not legal for me to ask patients with Medicaid and/or Medicare to pay for treatment out of their pocket unless I opt out of those programs completely for a period of years. I can’t do that because some of the other treatment facilities that I work for do bill Medicaid.

So do I start taking Medicaid, with all its headaches, red tape and low re-imbursement? I don’t know. I don’t like the thought of it, but it will perhaps become a necessity. It will depend on reimbursement rates. Plus, I’ll be paid even less since I don’t have electronic medical records. Government programs have decreed that doctors without meaningful use electronic medical records will receive less money for Medicaid/Medicare patients than doctors with these programs.

I’m not against electronic medical records. I use them effectively at both of the opioid treatment programs. One program is completely paperless, and I like that much more than I ever thought. But in my small, one hundred patient office, I can’t afford any software for medical records. It’s not practical or feasible

Since I was trained and still am board-certified as an Internal Medicine doctor, I could fill my other days with primary care patients. I was talking to another doctor who was starting her own Suboxone practice, and she was wondering how to get by financially, only practicing Addiction Medicine. She too is a former Internal Medicine doctor. I suggested she could always do some primary care.

“Just shoot me in the head,” she said, summarizing my feeling exactly. I’ve never liked primary care as much as addiction medicine, to put it mildly.

Addicts are easier to deal with, and are often nicer people than the average soccer mom, demanding an antibiotic to treat her viral upper respiratory infection. But my biggest reason for preferring addiction medicine is that addicts get better. I never saw the big changes in health when I worked in primary care, like I do in people treated for addiction. Primary care feels like a step backwards. I don’t want to go back to treating non-compliant diabetics, and overweight people who won’t exercise. I’d prefer to keep my present patients, in whom I see an intense desire to get well.

I’m addicted to seeing the big changes that I see when I work in addiction medicine. I hope the new changes in healthcare will allow me to stay in the business of helping people change. Like the rest of the U.S., I’ll have to wait and see.

I’ve been relatively supportive of the Reckitt-Benckiser pharmaceutical company until now. I’m impressed this drug company was willing to market a medication (Suboxone, Subutex) to treat opioid addiction. Other companies may not have wanted the stigma of producing a medication to treat addicts, and Reckitt has done a great many beneficial things for opioids addicts. In the past they sponsored eight-hour training sessions that doctors needed to get the special license to prescribe Suboxone/Subutex. They have a patient-assistance program that can help up to two patients out of a hundred get free medication, a generous program. And their target patient population often lacks both money and insurance to pay for treatment.

But now they are starting to irritate me. At the ASAM conference last month, I heard doctors say how the Suboxone drug reps are starting to pressure them in to prescribing only the name-brand Suboxone film. I’ve encountered similar pressure, and it makes me cranky.

I know the score. Reckitt’s patent on the Suboxone and Subutex tablets has run out, and there are a few Subutex-equivalents now on the market, selling for about half the cost of the name-brand. Reckitt waited until both tablet’s patents were ready to expire to release the film, because the film will be protected under patent for years to come. From a business point of view, all of that makes good sense. And of course, now Reckitt wants doctors to switch to the new and improved film.

But if the drug company salesperson starts telling me how harmful Suboxone tablets are in order to get me to switch patients to the film…they will lose credibility. Am I to believe the same medication, Suboxone tablets, which you were pushing so hard two years ago now is dangerous and must be replaced by films?? No. If the company believed this, why did they release the tablets in the first place? And why wait until the tablet patent expires to release their new “safer” form?

I like the Reckitt-Benckiser drug rep who comes to my office. Let’s call her Mary. Mary is intelligent and personable, as drug reps tend to be. She’s been helpful, and listened to my concerns about the film when patients reported it was flaking and crumbling, a problem that does seem to have resolved

But now, she’s annoying me. She goes into her company’s song and dance and I can’t help needling her. Here’s a reproduction of a portion of one of our latest conversations as I remember it.

“Doctor, Are you at all concerned about the pediatric overdoses with the tablets?” Mary said.

“No I don’t often prescribe them to toddlers.”

Mary’s eyes get a little wide until I start to laugh.

“I’m not sure the films are safer than the tablets when it comes to pediatric overdoses.” I say. “I think it’s all about making sure the patient knows how to store them safely. I had a comment to my blog say the films were harder to keep track of than the tablets.”

“There have been pediatric overdose deaths with the tablets and none so far with the film.” Mary tells me in what I hear as a slightly accusatory tone.

“And the tablets have been on the market longer.” I counter, just to be contrary. I actually do think the films are less likely to cause accidental overdoses, because those packages are so hard to get open.

“And don’t you think the tablets are a relapse trigger? Nearly all patients had been addicted to opioid tablets, and using them to get high. Now if you prescribe a tablet to treat the addiction…the sound of pills rattling in a bottle is a trigger for many addicts. If the patient has snorted pills, they may misuse the tablets and crush them into a powder to snort.”

What gall, I thought. “Mary, why didn’t you tell me all of this two years ago when you were encouraging me to prescribe more Suboxone tablets? Why didn’t you tell me then I was triggering my patients to snort pills and endangering their children?” She and I both know she was touting the healing properties of Suboxone tablets two years ago, right up until the film was released onto the market in the fall on 2010.

Mary was silent for a long moment, apparently at a loss for words. This is a rare thing to see in a drug rep. finally, she said with a laugh, “It’s hard to try to sell against yourself.”

The drug company says the film is less divertible than the tablets because of the unique ten-digit number on each pouch. This number can be traced back to the patient for whom it was prescribed. If a patient sells his medication and it’s eventually confiscated by police, the authorities can tell who it came from. Plus, if the doctor wants to do a film count, the patient won’t have the correct numbers on the foil pouches if he’s sold them. All of that’s true, but doesn’t give the average addict/dealer much credit for intelligence. It’s likely the person wishing to sell Suboxone films would just open the pouch and remove the film, saving the pouch in case it’s needed later. The numbering of the pouches is a good idea, and according to some information I heard at the ASAM conference, it probably is a little less likely to be diverted. But pill and film counts don’t work unless doctors actually do them.

As far as the “snortability” of a tablet, I don’t know. I’ve been surprised by the number of blog commenters who snort their Suboxone tablets, so there’s some validity to the argument that the tablets are snortable and the films not snortable. But then I have had commenters say the film is easier to inject, so what do I make of that?

I have to cautiously evaluate each patient. I have patients that I am certain would never even think of selling their prescription. I have had patients I think could possibly be selling. I’ve done pill counts on them and for the most part was pleasantly surprised their count was correct. Then I’ve had patients fail pill counts, and I will no longer prescribe for them.

Risks of medications must be balanced. I do agree the film is somewhat better because it dissolves faster, and early reports show it’s less desirable on the black market than the films are. But for some patients, that name brand is unaffordable. If they have no insurance and will have to drop out of treatment unless a cheaper alternative can be found, I feel it’s OK to use the generic tablets. I take more precautions with those patients, and check their arms for track marks at office visits. I do more frequent pill counts. I do frequent urine drug screens. I don’t use generic buprenorphine in patients with a history of IV drug use.

Addiction treatment is expensive. If I can use caution and prescribe the generic to save a previously stable patient from dropping out of treatment because of the cost, I may do it, if the patient agrees to the above safeguards.

Opioid treatment centers that are able to offer a wider array of services than just dosing with methadone show better patient retention in treatment and better patient outcomes. This means that just dosing with methadone helps opioid addicts, but not as much as methadone plus addiction counseling. And methadone plus counseling helps, but not as much as when other services are added, like psychiatric care, primary medical care, help with employment, and family counseling services. (1)

The problem is, of course, these extra services cost more to the treatment program. If you want to offer psychiatric services, a psychiatrist must be hired, usually on a contract basis, to be available during dosing hours. If the program’s medical director is a psychiatrist, that doctor has to be paid for the extra time it takes to provide the extra care. More commonly, patients are referred to other places for low-cost psychiatric help.

It’s the same with medical care. In order to offer any level of primary care, you have to hire a doctor, unless patients are asked to pay extra for this. Most patients can barely afford basic treatment, so extra expenses can’t be obtained.

At my program I like to try to treat uncomplicated mental illness like depression and anxiety disorders, and non-chronic, low-intensity primary care illnesses. Of course I refer patients who need ongoing medical or psychiatric care, but I can provide interim care until they get an appointment. I think this helps patients because I already know their history of addiction and won’t prescribe anything that will interact with methadone. It doesn’t cost the patient anything to see me for these extra services, so it saves patients money. I can usually see them relatively quickly, without an appointment on the two days a week that I work at the clinic. It seems like a good thing all around.

But to do even this low intensity care, accreditation agencies have many guidelines.

Treatment centers usually strive to be certified by the Commission of the Accreditation of Rehabilitation Facilities (CARF). CARF personnel are invited to facilities for a voluntary inspection, hopefully to be given a sort of seal of approval by this agency. They inspect mental health, substance abuse treatment, and physical rehabilitation facilities, as well as youth and family service facilities. Accreditation is important because it demonstrates the facility is providing good care.

The good news is that our CARF survey went very well. We got a one-year accreditation, and the CARF surveyors were professional and knowledgeable. They had good things to say about our clinic regarding our dedication to our mission to help our patients. They said great things about the staff enthusiasm and outlook. The CARF people supported the idea of providing primary care to patients, but they had recommendations about how to implement a few policies and procedures around this care. This is what they recommended, verbatim:

F.2.a.(1) through F.2.b.(16)It is recommended that ongoing documented training and education on medications be provided to the person served, family members, individuals identified by the person served, the team, and service providers. This ongoing training should include how the medication works; risks associated with each medicine; the intended benefits as related to the behavior or symptom targeted by the medication; side effects, contraindications, and potential implications between medications and diet/exercise; risks associated with pregnancy; the importance of taking medications as prescribed, including, when applicable, the identification of potential obstacles to adherence; the need for laboratory monitoring; the rationale for each medication; early signs of relapse related to medication efficacy; signs of nonadherence to medication prescriptions, including alcohol, tobacco, caffeine, illicit drugs, and alternative medications; instructions on self-administration, when applicable; wellness management and recovery planning; and the availability of financial supports and resources to assist the persons served with handling the cost associated with medications.

F.a.(1) through F.4.c.(3)It is recommended that, when medications are prescribed for or provided to a person served 9including those self-administered medications), an up-to-date individual record of all medications, including nonprescription and nonpsychoactive medications, include the name of the medication; the dosage; the frequency; instructions for use, including the method/route of administration; and the prescribing professional. The program should provide ready access to the telephone number of a poison control center to the program personnel and the person served. Written procedures that address how the medication will be integrated into the overall plan of the person served should be available. There should be a process for identifying, responding to, documenting, and reporting medication reactions and actions to be followed in case of emergencies related to the use of medication.

F.5.a.through F.5.n. It is recommended that, as the organization prescribes medications, it implement written procedures that include compliance with all applicable local, state or provincial and federal laws and regulations pertaining to medications and controlled substances, including on-site pharmacy services and dispensing. Written procedures should include the active involvement of the persons served, when able, or their parents or guardians, when appropriate, in making decisions related to the use of medications; the availability of a physician, pharmacist, or qualified professional licensed to prescribe for consultation 24 hours a day, 7 days a week; documentation and reporting of observed and/or reported medication reactions and medication errors; and a review of past medication use, including effectiveness, side effects, and allergies or adverse reactions. Written procedures should include the identification of alcohol, tobacco, and other drug use; use of over-the-counter medications; use of medications by women of childbearing age; use of medications during pregnancy; special dietary needs and restrictions associated with medication use; necessary laboratory studies, tests, or other procedures, when applicable; documented assessment of abnormal involuntary movements at the initiation of treatment and every six months thereafter for persons served receiving typical antipsychotic medications; when possible, coordination with the physician(s) providing primary care needs; and review of medication use activities, including medication errors and drug reactions, as part of the quality monitoring and improvement system.

F.6.a. through F.6.f. If the organization provides prescribing of medications, it is recommended that it implement written procedures that include screening for common medical co-morbidities using evidence- or consensus-based protocols; evaluation of co-existing medical conditions for potential medications impact; identifying potential drug interactions, including the use of over the counter or homeopathic supplements; documentation or confirmation of informed consent for each medication prescribed, when possible; continuing a prescribed medication if a generic medication is not available; and continuity of medication use, when identified as a need in a transition plan for a person served.

F.7.a.through F.7.b.(2) It is recommended that, as an organization that provides prescribing of medications, it demonstrate, to the extent possible, the use of treatment guidelines and protocols to promote state-of-the-art prescribing and ensure the safety of the person served. It is also recommended that a program of medication utilization evaluation include measures of effectiveness and satisfaction of the person served.

F.8.a. through F.8.e.(2) As an organization that provides prescribing of medications, a documented peer review should be conducted at least annually on a representative sample of records of persons for whom prescriptions were provided in order to assess the appropriateness of each medication as determined by the needs and preferences of each person served and the efficacy of the medication. It should be used to determine if the presence of side effects, unusual effects, and contraindications were identified and addressed and if necessary tests were conducted and used to identify the use of multiple simultaneous medications and medication interactions.

F.9.a. through F.9.c. It is recommended that information collected from the peer review process be reported to applicable staff, used to improve the quality of the services provided, and incorporated into the organization’s performance improvement system.

Whew. I was overwhelmed. Plus, I’m a relatively intelligent person, but I’m still fuzzy on exactly what they mean. Here are some of my concerns:

I already record a full history and physical on each patient, and have a record of all medications they’re taking. But apparently the way I’m doing this isn’t adequate, and I’m left to wonder what the specifics of their recommendations would look like..

Signed informed consent in order to be written a prescription? This is not generally done in primary care. I’m not sure what the justification for this is in a methadone clinic population.

Apparently I need to give each patient a written summary of all side effects of a prescribed medication. I don’t do this in primary care, because the pharmacy does all of that. Each time a prescription is filled, they give a long sheet of possible side effects. What’s the rationale for redundance?

These are only a few of my concerns.

When faced with the task of complying with all of these recommendations, many clinics understandably decide it’s just easier to tell patients to see their own doctor for anything they need besides the methadone.

CARF does a needed service, but in many matters I think it’s important to pull back to see the whole picture. It’s similar to the paperwork requirements for Medicaid – most of this paperwork is probably needed in some form or fashion, but surely there’s a better way to do this than to ask counselors to do a mountain of paperwork when they’d rather be doing counseling.

Regulations are important. But don’t make the regulations so obscure and onerous that most clinics stop providing any extra care.

I called Reckitt-Benckiser for information about the crumbling Suboxone films reported by my patients. I spoke with a nurse who was familiar with the problem. She said that around the end of May of this year, the drug company began getting reports of crumbling Suboxone films. As it turns out, three lots of film were affected, with problems of dry and crumbling films. R-B asked pharmacies to pull the affected lots from their shelves for return to the company. Apparently there was a malfunction during manufacturing of affected lots starting with an “M” or “L.” The nurse I spoke with acknowledged that some pharmacies may still be inadvertently dispensing films from the affected lots, but the problem has been fixed and shouldn’t recur with future lots.

She said the company reported this problem to the FDA, and also did analysis of crumbling films returned to R-B. She says the scientists’ tests showed that despite the crumbling, the appropriate amount of buprenorphine was released from these films. However, she recommended that patients return crumbling films to their pharmacy. The pharmacy should replace them, and Reckitt-Benckiser will credit the pharmacy. This goes only for unused films, however. Used films will not be replaced, for obvious reasons. Patients can also call Reckitt-Benckiser at 1-877-782-6966 for more information. You should have the lot number off the box or film envelops to report problems.

I’m pleased with the company’s responsiveness to problems. I was pleasantly surprised with the amount of knowledge the nurse at R-B had about addiction.